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Analytical Scientist for Pharmaceutical Method Validation
hace 2 meses
Job Title: Analytical Scientist for Pharmaceutical Method Validation
Job Summary:
We are seeking a highly skilled Analytical Scientist to join our team at Validation & Engineering Group, Inc. The successful candidate will be responsible for designing, executing, and evaluating method development protocols for new and existing methods in the pharmaceutical industry.
Main Responsibilities:
- Design, execute, and evaluate method development protocols for new and existing methods to ensure implementation of a feasible, efficient, rugged, and robust method.
- Support technical aspects of test method ruggedness and robustness processes.
- Support the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
- Coordinate projects to assure successful and timely execution, issuance, and updating of detailed time and event schedules.
- Lead analytical special projects to accomplish company goals and objectives on a timely and effective manner.
- Support laboratory instrument qualification including knowledge in Maximo, Infinity.
- Generate IOQ and PQ reports for the qualification of Analytical Instruments.
- Provide timely and efficient technical reports to document all analytical improvement or investigation projects.
- Evaluate and appraise method and instrument changes in regard to regulatory requirements.
- Keep current with emerging technologies, new instrumentation, and regulatory expectations relative to the pharmaceutical/development laboratory operations.
- Train Technical Operations analysts to perform existing and/or new analytical methods and generate training.
- Verify consistency with other site procedures and/or specifications.
Requirements:
- BS Degree in Natural Science in Biochemistry or Chemistry.
- Five years of experience in pharmaceutical industry with at least two years of experience in method development/transfer of biomolecules for BS Degree holders. Two years of experience in pharmaceutical industry in method development/transfer of biomolecules for Master Degree holders.
- Technical knowledge of proteins handling and analysis with specific experience in biomolecules method optimization and troubleshooting.
- Broad experience with analytical instrumentation and techniques (e.g. HPLC, GC, UV, FTIR, MS, CE, SDS-PAGE, SEC, ELISA).
- Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.
- Computer literacy (Microsoft office, etc) and presentation skills (English/Spanish).
- Technical writing and oral communication skills (English/Spanish).
- Leadership skills, time management, planning, and organization capabilities.
- Excellent interpersonal skills and the ability to interact with people at all levels.
- Project management skills.
- Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving skills.
- Willingness to work irregular hours, rotative shifts, weekends, and holidays when necessary.
About Us:
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
